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CI: Gastric vs. Small Bowel Feeding (2011)

Citation:

Acosta-Escribano J, Fernández-Vivas M, Grau Carmona T, Caturla-Such J, Garcia-Martinez M, Menendez-Mainer A, Solera-Suarez M, Sanchez-Payá J. Gastric vs. transpyloric feeding in severe traumatic brain injury: A prospective, randomized trial. Intensive Care Med. 2010 Sep; 36 (9): 1,532-1,539.

PubMed ID: 20495781
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

To evaluate incidence of VAP with transpyloric vs. gastric feeding tube placement in severe traumatic brain injury patients.

Inclusion Criteria:
  • Between 18 and 80 years old
  • GCS less than nine
  • APACHE II score between 15 and 30
  • SOFA index less than six (excluding neurological variable)
  • Mechanical ventilation required upon admission
  • Expected to need artificial nutrition at least five days
  • Patient or closest relative gave informed consent.

 

Exclusion Criteria:
  • Chronic renal failure (plasma creatinine greater than 2mg/dL)
  • Hepatic failure (bilirubin greater than 3mg/dL)
  • Contraindication for EN (intestinal inflammatory disease, past history gastric resection, abdominal surgery within past two months previous to inclusion, facial trauma)
  • Treatment with steroids or immunosuppressive drugs
  • Traumatic spinal cord injury
  • Pregnancy
  • BMI>35kg/m2
  • Severe malnutrition with BMI<18 kg/m2
  • Life expectancy less than five days
  • Participation in another clinical study
  • Refused consent.
Description of Study Protocol:

Recruitment

Admitted to ICU for TBI; entered into study within 24 hours and followed for 30 days or until discharge (if sooner)

Design

RCT: Randomized in 1:1 ratio to one of two treatment groups

Blinding

No

Intervention 

Gastric or SB feeding tube placement; prokinetics used in patients with elevated GRV

Statistical Analysis 

  • Study power set at 80% to detect difference between the two types of EN routes of at least 25% in absolute terms or a risk reduction of 0.3 for development of nosocomial pneumonia during ICU stay with alpha error of 5%. Yielded sample size of 104 (52 per group)
  • Intent to treat analysis
  • Continuous data assessed for normality; Student’s Ttest for normal distribution and Mann-Whitney U test for non-normal distributions with 95% CI and α=0.05
  • Two-tailed Chi square and Fisher test correction for proportions
  • Odds ratio with 95% CI calculated for incidence of nosocomial infections and GI complications.
Data Collection Summary:

Timing and method of measurements  

  • Baseline: CRP, cholesterol, prealbumin, albumin
  • SOFA score: Daily
  • GRV: Every six hours on first day and every 12 hours thereafter (if GRV>200mL, EN stopped for six hours and then restarted at previous rate).

Dependent variables (outcomes) 

  • Primary:
    • Incidence of nosocomial pneumonia (CPIS criteria less than six); VAP (appeared >48 hours after admission)
    • Other hospital acquired infection
  • Secondary:
    • Enteral feeding GI complications (abdominal distension, GRV>200 mL, vomiting, diarrhea (at least five liquid stools in 24-hour period or volume of 2,000mL per day, aspiration (diet presence in airway or respiratory tract.

Independent Variables (intervention or procedure) 

Gastric or SB feeding tube placement.

 

Description of Actual Data Sample:
  • Initial N (percent male): 104 (86% male)
  • Final N (percent attrition): 104
    • Five patients died before five days, but data analyzed by intent-to-treat analysis
  • Age: 38.4±19.5 years
  • Ethnicity: Not described
  • Other relevant setting characteristics: Not applicable
  • Anthropometrics or other relevant subject characteristics: 
    • Mean APACHE II score 17±5 (P=0.2)
    • Mean SOFA score 5±2 (P=0.9)
    • Time to clinical stabilization: gastric 6±10 hours vs. SB 4±8 hours (P=0.05)
  • Location: Spain.

 

Summary of Results:

Key Findings

Nutrition goal more likely to be met with SB feeding
Outcomes Gastric Feeding Small Bowel Feeding Statistical Significance of Group Difference
Total pneumonia 31/54 (55%) 16/50 (34%) OR 0.3 (95% CI; 0.1-0.7) P<0.01
Other infections 7/54 (13%) 13/50 (26%) OR 2.3 (95% CI; 0.9-6.5) P=0.07 
Mechanical ventilation (days) 8.9±4 7.3±4 P=0.1 
ICU LOS (days) 18±7 16±9 P=0.2 
Hospital LOS (days) 41±28 38±24 P=0.6
Mean efficacious volume (percent goal met) 84±15% 92±7% P=0.01 
EN withdrawal 10 (18%) 3 (6%) 0.3 (95% CI 0.1-1.1) P=0.06 
Increased GRV 15/54 (28%) 3/50 (6%)  0.2 (95% CI 0.1-0.6) P=0.003 

 

Author Conclusion:

EN via SB feeding tube reduces incidence of pneumonia and improves nutritional efficacy in TBI patients.

Funding Source:
Other: No funding source reported
Reviewer Comments:
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? Yes
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? Yes
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes